The FDA approved the Optilume BPH catheter system, a minimally invasive surgical therapy used for the treatment of lower urinary tract symptoms.
The treatment was developed by Urotronic, a medical technology company that specializes in treating urological conditions, and uses a drug-coated balloon to treat benign prostatic hyperplasia by dilating the urethra and allowing improved urine flow, Urotronic said in a July 11 news release.
The system results in substantial, immediate improvements in BPH patient symptoms and functions that was maintained throughout the four-year follow-up period, according to findings from clinical trials.